Quality of life (QoL) as predictive mediator variable for survival in patients with intracerebral neoplasma during radiotherapy

Background: The prognosis for patients with malignant astrocytoma or brain metastases is often fatal despite intensive therapy. Therefore we wished to elucidate whether the quality of life (QoL) is a determinant of overall survival (OAS). Patients and Methods: From 1997 to 2000 153 patients with brain tumours were screened; 39 patients (26%) refused to participate and further 47 patients were excluded (cerebral impairment 14%, amaurosis/language problems 3%, Karnofsky performance score < 50% 7%, death 8%, non-compliance 7%). Thus, 57 patients were analysed (33 with primary brain tumours, 24 with brain metastases). With the FACT-G questionnaire cancer-specific aspects of health-related QoL were assessed. Results: Patients with metastases showed a lower QoL in the physical sphere than patients with astrocytoma, but there were no significant differences in OAS. Median survival of patients with good QoL was 31.3 months versus 14.2 months in patients with bad QoL. Only the two variables `living with a spouse' and FACT-G sum score had a statistically significant influence on survival (p = 0.033 and p = 0.003) modelled by the Cox-PH regression. Patients who did not live with a spouse had shorter survival times than the other patients. Conclusion: Health-related QoL can serve to identify a patient group with higher risks of death

Radiotherapy: Impact of quality of life and need for psychological care: Results of a longitudinal study

Background: In the framework of a prospective longitudinal study, the quality of life (QoL) and support requirements of patients from a university hospital department of radiotherapy were evaluated for the first time by means of established psychodiagnostic questionnaires. Patients and Methods: At first, 732 patients were screened, of whom 446 (60.9%) fulfilled the criteria for inclusion; 39.1% did not (refusals 21.0%, low Karnofsky performance status 6.6%, management problems 3.4%, language barriers 3.0%, cognitive restrictions 2.6%, death 2.5%). Disease-specific aspects of QoL (Functional Assessment of Cancer Treatment - General, FACT-G) and moderating variables {[}Social Support Scale (SSS), Disease Coping (FKV), Self-Assessment Depression Scale (SDS), and Self-Defined Care Requirements (BB)] were self-rated by patients with different tumor types before radiotherapy (T1), after radiotherapy (T2), and 6 weeks after the end of radiotherapy (T3). We studied 265 patients (157 male, 108 female; median age 58.6 years) with complete data of three time points. Results: In general, QoL of patients decreased significantly over all time points in all subscales. Social support was rated high and remained constant throughout the treatment. Apparent coping mechanisms were active problem-oriented coping, leisure activities, and self-support. The patients' depression proved to be an important and constant factor without significant changes. The support requirement is characterized by the need for more medical information and dialogue with a physician. Conclusions: Early specific support from personnel with radiotherapeutic skills, during the disease-coping process as well as during rehabilitation, should be a permanent component of an integrated radiooncological treatment schedule

Coping of cancer patients during and after radiotherapy - a follow-up of 2 years

Aim: We wanted to understand coping strategies specific to different phases up to two years after radiotherapy, to identify patients who are at higher risk of mood disturbances and to characterise the association between coping strategies and psychosocial adaptation. Patients and Methods: From 1997 to 2001, 2,169 patients with different diagnoses were screened (27.8% refused to participate). Data of 276 patients from the beginning of radiotherapy (ti1) and 5 follow-up investigations (ti6/2 years) could be analysed. With the FKV ( Freiburg Questionnaire Coping with Disease) cancer-specific coping aspects were assessed. The association between coping styles and psychosocial adaptation was evaluated using the Questionnaire on Stress in Cancer Patients (QSC) and the questionnaire on Functional Assessment of Cancer Treatment (FACT-G). Results: `Active problem-orientated' coping and `distractions' are the most important coping strategies. Only `active problem-orientated' and `depressive' coping showed a significant decrease. We observed higher means on the scales of the FKV in women. Marital status ( single, married, divorced/widowed) had a significant influence on active problem-orientated coping and spirituality. Age, children, education, T/M status and curative/ palliative intention of treatment had no influence on coping styles. Breast cancer patients and lymphoma patients demonstrated the highest use of coping strategies after radiotherapy with a significant decrease of `active problem-orientated coping'. Depressive coping and minimizing importance at ti1 were associated with high psychosocial distress and low quality of life (QoL) at ti6. Conclusion: The correlation of coping mechanisms at the beginning of radiotherapy with low QoL and high psychosocial stress at 2 years could help to identify patients at risk for low psychosocial adaptation. Psychooncologically trained teams of physicians would best correspond to this profile of needs and would contribute significantly to an ameliorated adaptation of patients to cancer which could lead to higher life satisfaction

The experience of accommodating privacy restrictions during implementation of a large-scale surveillance study of an osteoporosis medication.

PurposeTo explore whether privacy restrictions developed to protect patients have complicated research within a 15-year surveillance study conducted with US cancer registries.MethodsData from enrolling 27 cancer registries over a 10-year period were examined to describe the amount of time needed to obtain study approval. We also analyzed the proportion of patients that completed a research interview out of the total reported by the registries and examined factors thought to influence this measure.ResultsThe average length of the research review process from submission to approval of the research was 7 months (range, &lt;1 to 24 months), and it took 6 months or more to obtain approval of the research at 41% of the cancer registries. Most registries (78%) required additional permission steps to gain access to patients for research. After adjustment for covariates, the interview response proportion was 110% greater (ratio of response proportion = 2.1; 95% confidence interval: 1.3, 3.3) when the least restrictive versus the most restrictive permission steps were required. An interview was more often completed for patients (or proxies) if patients were alive, within a year of being diagnosed, or identified earlier in the study.ConclusionsLengthy research review processes increased the time between diagnosis and provision of patient information to the researcher. Requiring physician permission for access to patients was associated with lower subject participation. A single national point of entry for use of cancer registry data in health research is worthy of consideration to make the research approval process efficient. © 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley &amp; Sons Ltd

The influence of cardiovascular morbidity on the prognosis in prostate cancer. Experience from a 12-year nationwide Danish population-based cohort study

<p>Abstract</p> <p>Background</p> <p>To determine the impact of preexisting ischemic heart disease (IHD) and stroke on overall survival in prostate cancer patients.</p> <p>Methods</p> <p>We conducted a cohort study of patients with incident prostate cancer registered in the Danish Cancer Registry from 1997 through 2008. We identified patients diagnosed with IHD or stroke prior to the date of prostate cancer diagnosis in the Danish National Patient Registry. We constructed Kaplan-Meier curves to analyze time to death and Cox regression was used to estimate hazard ratios (HRs) to compare mortality rates by preexisting IHD or stroke status, adjusting for age, stage, comorbidity, and calendar period.</p> <p>Results</p> <p>Of 30,721 prostate cancer patients, 4,276 (14%) had preexisting IHD and 1,331 (4%) preexisting stroke. Crude 1- and 5-year survival rates were 85% and 44% in men without preexisting IHD or stroke, 81% and 36% in men with preexisting IHD, and 78% and 27% in men with preexisting stroke. Adjusted HRs were 1.05 (95% CI 1.00-1.10) for patients with IHD and 1.20 (95% CI 1.12-1.30) for patients with stroke compared with patients without preexisting IHD or stroke.</p> <p>Conclusions</p> <p>Preexisting IHD had minimal impact on mortality in prostate cancer patients, whereas overall mortality was 20% higher in prostate cancer patients with preexisting stroke compared to those without IHD or stroke. These results highlight the importance of differentiating between various comorbidities.</p

Assessment of Birth Defects and Cancer Risk in Children Conceived via in Vitro Fertilization in the US

Importance: Children with birth defects have a greater risk of developing cancer, but this association has not yet been evaluated in children conceived with in vitro fertilization (IVF). Objective: To assess whether the association between birth defects and cancer is greater in children conceived via IVF compared with children conceived naturally. Design, Setting, and Participants: This cohort study of live births, birth defects, and cancer from Massachusetts, New York, North Carolina, and Texas included 1000639 children born to fertile women and 52776 children conceived via IVF (using autologous oocytes and fresh embryos) during 2004-2016 in Massachusetts and North Carolina, 2004-2015 in New York, and 2004-2013 in Texas. Children were followed up for an average of 5.7 years (6008985 total person-years of exposure). Data analysis was conducted from April 1 to August 31, 2020. Exposures: Conception by IVF for state residents who gave birth to liveborn singletons during the study period. Birth defect diagnoses recorded by statewide registries. Main Outcomes and Measures: Cancer diagnosis as recorded by state cancer registries. Cox proportional hazards regression models were used to estimate hazard ratios (HRs) and 95% CIs for birth defect-cancer associations separately in fertile and IVF groups. Results: A total of 1000639 children (51.3% boys; 69.7% White; and 38.3% born between 2009-2012) were in the fertile group and 52776 were in the IVF group (51.3% boys; 81.3% White; and 39.6% born between 2009-2012). Compared with children without birth defects, cancer risks were higher among children with a major birth defect in the fertile group (hazard ratio [HR], 3.15; 95% CI, 2.40-4.14) and IVF group (HR, 6.90; 95% CI, 3.73-12.74). The HR of cancer among children with a major nonchromosomal defect was 2.07 (95% CI, 1.47-2.91) among children in the fertile group and 4.04 (95% CI, 1.86-8.77) among children in the IVF group. The HR of cancer among children with a chromosomal defect was 15.45 (95% CI, 10.00-23.86) in the fertile group and 38.91 (95% CI, 15.56-97.33) in the IVF group. Conclusions and Relevance: This study found that among children with birth defects, those conceived via IVF were at greater risk of developing cancer compared with children conceived naturally

The risks of birth defects and childhood cancer with conception by assisted reproductive technology

STUDY QUESTION: Is there an association between fertility status, method of conception and the risks of birth defects and childhood cancer? SUMMARY ANSWER: The risk of childhood cancer had two independent components: (i) method of conception and (ii) presence, type and number of birth defects. WHAT IS KNOWN ALREADY: The rarity of the co-occurrence of birth defects, cancer and ART makes studying their association challenging. Prior studies have indicated that infertility and ART are associated with an increased risk of birth defects or cancer but have been limited by small sample size and inadequate statistical power, failure to adjust for or include plurality, differences in definitions and/or methods of ascertainment, lack of information on ART treatment parameters or study periods spanning decades resulting in a substantial historical bias as ART techniques have improved. STUDY DESIGN, SIZE, DURATION: This was a population-based cohort study linking ART cycles reported to the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) from 1 January 2004 to 31 December 2017 that resulted in live births in 2004–2018 in Massachusetts and North Carolina and live births in 2004–2017 in Texas and New York. A 10:1 sample of non-ART births were chosen within the same time period as the ART birth. Non-ART siblings were identified through the ART mother’s information. Children from non-ART births were classified as being born to women who conceived with ovulation induction or IUI (OI/IUI) when there was an indication of infertility treatment on the birth certificate, and the woman did not link to the SART CORS; all others were classified as being naturally conceived. PARTICIPANTS/MATERIALS, SETTING, METHODS: The study population included 165 125 ART children, 31 524 non-ART siblings, 12 451 children born to OI/IUI-treated women and 1 353 440 naturally conceived children. All study children were linked to their respective State birth defect registries to identify major defects diagnosed within the first year of life. We classified children with major defects as either chromosomal (i.e. presence of a chromosomal defect with or without any other major defect) or nonchromosomal (i.e. presence of a major defect but having no chromosomal defect), or all major defects (chromosomal and nonchromosomal), and calculated rates per 1000 children. Logistic regression models were used to generate adjusted odds ratios (AORs) and 95% CIs of the risk of birth defects by conception group (OI/IUI, non-ART sibling and ART by oocyte source and embryo state) with naturally conceived children as the reference, adjusted for paternal and maternal ages; maternal race and ethnicity, education, BMI, parity, diabetes, hypertension; and for plurality, infant sex and State and year of birth. All study children were also linked to their respective State cancer registries. Cox proportional hazards regression models were used to estimate hazard ratios (HRs) and 95% CIs of cancer by birth defect status (including presence of a defect, type and number of defects), and conception group. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 29 571 singleton children (2.0%) and 3753 twin children (3.5%) had a major birth defect (chromosomal or nonchromosomal). Children conceived with ART from autologous oocytes had increased risks for nonchromosomal defects, including blastogenesis, cardiovascular, gastrointestinal and, for males only, genitourinary defects, with AORs ranging from 1.22 to 1.85; children in the autologous-fresh group also had increased risks for musculoskeletal (AOR 1.28, 95% CI 1.13, 1.45) and orofacial defects (AOR 1.40, 95% CI 1.17, 1.68). Within the donor oocyte group, the children conceived from fresh embryos did not have increased risks in any birth defect category, whereas children conceived from thawed embryos had increased risks for nonchromosomal defects (AOR 1.20, 95% CI 1.03, 1.40) and blastogenesis defects (AOR 1.74, 95% CI 1.14, 2.65). The risk of cancer was increased among ART children in the autologous-fresh group (HR 1.31, 95% CI 1.08, 1.59) and non-ART siblings (1.34, 95% CI 1.02, 1.76). The risk of leukemia was increased among children in the OI/IUI group (HR 2.15, 95% CI 1.04, 4.47) and non-ART siblings (HR 1.63, 95% CI 1.02, 2.61). The risk of central nervous system tumors was increased among ART children in the autologous-fresh group (HR 1.68, 95% CI 1.14, 2.48), donor-fresh group (HR 2.57, 95% CI 1.04, 6.32) and non-ART siblings (HR 1.84, 95% CI 1.12, 3.03). ART children in the autologous-fresh group were also at increased risk for solid tumors (HR 1.39, 95% CI 1.09, 1.77). A total of 127 children had both major birth defects and cancer, of which 53 children (42%) had leukemia. The risk of cancer had two independent components: (i) method of conception (described above) and (ii) presence, type and number of birth defects. The presence of nonchromosomal defects increased the cancer risk, greater for two or more defects versus one defect, for all cancers and each type evaluated. The presence of chromosomal defects was strongly associated with cancer risk (HR 8.70 for all cancers and HR 21.90 for leukemia), further elevated in the presence of both chromosomal and nonchromosomal defects (HR 21.29 for all cancers, HR 64.83 for leukemia and HR 4.71 for embryonal tumors). Among the 83 946 children born from ART in the USA in 2019 compared to their naturally conceived counterparts, these risks translate into an estimated excess of 761 children with major birth defects, 31 children with cancer and 11 children with both major birth defects and cancer. LIMITATIONS, REASONS FOR CAUTION: In the SART CORS database, it was not possible to differentiate method of embryo freezing (slow freezing versus vitrification), and data on ICSI were only available in the fresh embryo ART group. In the OI/IUI group, it was not possible to differentiate type of non-ART treatment utilized, and in both the ART and OI/IUI groups, data were unavailable on duration of infertility. Since OI/IUI is underreported on the birth certificate, some OI/IUI children were likely included among the naturally conceived children, which will decrease the difference between all the groups and the naturally conceived children. WIDER IMPLICATIONS OF THE FINDINGS: The use of ART is associated with increased risks of major nonchromosomal birth defects. The presence of birth defects is associated with greater risks for cancer, which adds to the baseline risk in the ART group. Although this study does not show causality, these findings indicate that children conceived with ART, non-ART siblings, and all children with birth defects should be monitored more closely for the subsequent development of cancer. STUDY FUNDING/COMPETING INTEREST(S): This project was supported by grant R01 HD084377 from the National Institute of Child Health and Human Development. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Child Health and Human Development, or the National Institutes of Health, nor any of the State Departments of Health which contributed data. M.L.E. reports consultancy for Ro, Hannah, Dadi, Sandstone and Underdog; presidency of SSMR; and SMRU board member. The remaining authors report no conflict of interest